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Manager/Senior Manager API

  • Standort

    UK

  • Salary

    Negotiable

  • Sector

    Forschung und Entwicklung

  • Job Ref

    87292

  • Contact

    Will Godfrey

  • Published

    27 Tage her

Übersicht

A fantastic opportunity for an experienced Manager/Senior Manager API offering the flexibility of remote working and a few days a month on site in Wiltshire (or can be fully site based if this is your preference)

Benefits

  • Remote Working

  • Pension scheme

  • Life assurance

  • DIS

  • Health insurance

  • 25 days annual leave, plus bank holidays

Job Description

To provide technical expertise on all aspects of drug substance manufacture and control and to manage external API contract manufacturing organisations (CMO's) to ensure supply of drug substance and intermediates to meet project objectives.

Role Objectives

  • To provide CMC expertise (technical and regulatory) to support research activities up to first/second GMP batch stage for use in toxicology and clinical studies.

  • To ensure appropriate supply of drug substance and intermediates to meet project objectives.

  • To ensure that appropriate standards of GMP and GCP are met when required.

Responsibilities

  • To work closely with the medicinal chemistry team to ensure timely supply of custom made building blocks, advanced research intermediates and API.

  • Project management of API Contract Research and Manufacturing Organisations

  • Manage the development and scale up of lead candidates to support non-GLP toxicology studies. As appropriate, progress candidates into early phase development.

  • Ensuring appropriate Quality or Technical Agreements are in place with all CMOs undertaking GMP activities.

  • To assist with the compilation of CMC sections of regulatory filings (clinical trial applications, IND)

  • To assist with auditing activities

  • To work in accordance with SOPs and Policies

Required Skills

  • Chemistry qualifications - preferably to PhD level

  • Demonstrated experience of process development and scale up of processes to kilo lab scale.

  • Demonstrated experience of successful delivery of early phase API manufacture to preclinical supply through to Phase II.

  • Demonstrated experience of managing API contract manufacturing organisations.

  • Understanding of the data requirements and documentation needed (Module 3) to obtain successful regulatory approval at clinical trial stage would be advantageous.

  • Trained in GMP.

For immediate consideration please forward your most up to date CV

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.